Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of IM on the Molecular Response in Patients With LMC in Chronic Phase Treated With IM 400 mg / Day for at Least Two Years, Complete Cytogenetic Response for at Least One Year
The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with
CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response
and major molecular response rate) is dependent on the residual plasma Imatinib. This study
aims to evaluate the effectiveness of a strategy for dose adjustment of Imatinib Mesylate
based on the measurement of the residual plasma imatinib in patients treated for at least 2
years Imatinib 400 mg / d in complete cytogenetic response for at least 1 year.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Compare the effectiveness of a strategy to adapt dosage of Imatinib Mesylate (based on residual plasma IM), the effectiveness of a standard (IM fixed dose of 400 mg / day )
Compare the effectiveness of a strategy to adapt dosage of Imatinib Mesylate (based on residual plasma IM), the effectiveness of a standard (IM fixed dose of 400 mg / day )
07/2013 (up to 12 months)
No
ETIENNE Gabriel, MD
Study Chair
Institut Bergonié
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
IB2009-07
NCT01827930
July 2009
December 2014
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